510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K071866Substantially Equivalent

Ntrainer System

Kcbiomedix, Inc., Lees Summit MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071866 is the FDA 510(k) clearance record for NTRAINER SYSTEM, a class II device, cleared for Kcbiomedix, Inc. on under FDA product code HCC (Device, Biofeedback). FDA records list one 510(k) clearance for Kcbiomedix, Inc. As of , FDA records show no recalls naming K071866.

Clearance record

Decision date
Received
(210 days to decision)
Product code
HCC Device, Biofeedback
Regulation
21 CFR 882.5050
Device class
Class II
Review panel
Neurology
Applicant
Kcbiomedix, Inc. 4200 SW Sapelo Dr., Lees Summit MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HCC

Trailing 12 months

FDA records hold no clearances under product code HCC in the trailing twelve months.

FDA records show no clearances under product code HCC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HCC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260